KIM-2020-NIVO-BTC

NCT02829918 📎

Regimen

Experimental
Nivolumab 240 mg IV q2w until progression or toxicity
Control
single-arm / no comparator

Population

Advanced BTC (unresectable/metastatic) refractory to ≥1 prior therapy (predominantly GemCis-refractory); ICC ~61%, ECC ~19%, GBC ~20%; US multicenter; all patients received prior GemCis or GemCis-based therapy; PD-L1 unselected

Key finding

Kim 2020 demonstrated that nivolumab monotherapy has meaningful single-agent activity in refractory BTC with a 22% ORR — noteworthy given historical single-agent ORRs of 5-10% in chemotherapy-refractory BTC. The 14.2-month median OS in a refractory population is surprisingly favorable, likely reflecting selection bias toward good-PS patients. Notably, responses appeared enriched in MMR-deficient/MSI-H tumors (2 patients) and those with high TMB. This study informed the design of IO combination trials and highlighted that a subset of BTC patients (MSI-H, high TMB) may be IO-sensitive, fueling the biomarker-stratified precision approach (now chapter 4 scope).

Source: PMID 32352498

Timeline

    Guideline citations

    • NCCN BTC (p.39)